NCT02172729

Brief Summary

To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block. The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

June 20, 2014

Last Update Submit

November 17, 2014

Conditions

Healthy

Keywords

adductor canal blockhealthy volunteersUS-guided peripheral nerve blocklower limbdurationMuscle StrengthAnesthetics, LocalSensation

Outcome Measures

Primary Outcomes (1)

  • Duration of sensory block assessed with pinprick.

    Duration is defined as the time from block performance until recovery of sensation to pin-prick stimulus, assessed at 30 and 60 minutes post block, and thereafter every hour.

    0-10 hours

Secondary Outcomes (7)

  • Duration of sensory block assessed by heat pain detection threshold

    0-10 hours

  • Duration of sensory block assessed by warmth detection threshold

    0-10 hours

  • Duration of sensory block assessed by pain during 1 minute of warmth stimulation

    0-10 hours

  • Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation

    0-10 hours

  • Duration of sensory block assessed by cold sensation with an alcohol swab

    0-10 hours

  • +2 more secondary outcomes

Study Arms (2)

ACB with lidocaine 5 mg/ml

EXPERIMENTAL

Adductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus

Drug: Adductor canal block with 20 ml lidocaine, single bolus

ACB with lidocaine 15 mg/ml

EXPERIMENTAL

Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus

Drug: Adductor canal block with 20 ml lidocaine, single bolus

Interventions

Adductor canal block with 20 ml lidocaine, single bolusDRUG

Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml

ACB with lidocaine 15 mg/mlACB with lidocaine 5 mg/ml

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 1
  • Body mass index 18-25

You may not qualify if:

  • Allergy to study medication
  • Earlier trauma or surgery to lower limb
  • Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Jaeger P, Koscielniak-Nielsen ZJ, Hilsted KL, Grevstad U, Siersma V, Fabritius ML, Dahl JB. Effect of Total Dose of Lidocaine on Duration of Adductor Canal Block, Assessed by Different Test Methods: A Report of Two Blinded, Randomized, Crossover Studies in Healthy Volunteers. Anesth Analg. 2016 Oct;123(4):1026-32. doi: 10.1213/ANE.0000000000001517.

    PMID: 27537926DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Pia Jæger, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Jørgen B Dahl, Professor

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 24, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

DK(1)